The following data is part of a premarket notification filed by John O. Butler Co. with the FDA for Butler Antibacterial Interdental Toothbrush.
| Device ID | K974761 |
| 510k Number | K974761 |
| Device Name: | BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH |
| Classification | Toothbrush, Manual |
| Applicant | JOHN O. BUTLER CO. 333 WEST WACKER DR. Chicago, IL 60606 |
| Contact | Thomas J Muldoon |
| Correspondent | Thomas J Muldoon JOHN O. BUTLER CO. 333 WEST WACKER DR. Chicago, IL 60606 |
| Product Code | EFW |
| CFR Regulation Number | 872.6855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-19 |
| Decision Date | 1998-06-16 |